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Clinical Trial Summary

This integrated assessment consists of two studies, 603A and 603B, to be carried out sequentially in a common study population. Participating subjects will be informed of the trial design and their consent to participate in both studies will be obtained in a single consent form. Approximately 680 male or female adult subjects will be enrolled.


Clinical Trial Description

THR-1442-C-603 is an integrated assessment of the potential utility of bexagliflozin tablets, 20 mg for the treatment of essential hypertension. It is composed of two studies, 603A and 603B, measuring effects in a common population.

Approximately 680 male or female adult subjects who exhibit an office seated blood pressure ≥140 mm Hg and <180 mm Hg, and who are taking no more than 4 anti-hypertension medications will be enrolled in study 603A.

Upon returning to the investigational site to surrender the ambulatory monitor at the conclusion of study 603A, subjects will begin participation in study 603B. They will receive a 12-week supply of bexagliflozin tablets, 20 mg. At week 12 (cumulative week 24) subjects will visit the investigational site to consume the bexagliflozin tablet and to be fitted with an ambulatory monitor to record their baseline mean blood pressure. The following day, subjects will be randomized 1:1 to receive a 12-week supply of bexagliflozin tablets, 20 mg or bexagliflozin tablets, placebo. Assignment to the active or placebo arm will be balanced.

An assessment of bexagliflozin population pharmacokinetics (PK) will also be conducted, to include approximately 200 subjects. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03514641
Study type Interventional
Source Theracos
Contact
Status Active, not recruiting
Phase Phase 2/Phase 3
Start date October 18, 2017
Completion date March 31, 2019

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